HEALTH TECHNOLOGY ASSESSMENT FOR CHIMERIC ANTIGEN RECEPTOR (CAR) T-CELL THERAPIES FOR CANCER
Author(s)
Hollier-Hann G1, Brown A1, Ralston S2, Curry A2, Cork D1
1SIRIUS Market Access, Newcastle upon Tyne, UK, 2SIRIUS Market Access, London, UK
OBJECTIVES: Chimeric antigen receptor (CAR) T-cell therapy involves genetically engineering T-cells to produce CARs which, when infused back into the patient, recognise and kill cancer cells expressing the antigen. This study aims to identify and review HTAs for CAR-T therapy in the EU and US. METHODS: HTA searches for CAR-T therapy were performed across the UK, US, France, and Germany. Searches for additional data relating to costs and cost-effectiveness analysis were conducted in Pubmed, Embase, Cochrane library, Econlit, and ISPOR. RESULTS: An NIHR-funded independent academic group performed a mock appraisal assessing CAR-T therapy in relapsed/refractory B-cell acute lymphoblastic leukaemia (B-ALL) (February 2017) to test the applicability of NICE appraisal methodology to regenerative medicines. Uncertainty around limited clinical evidence and the impact of different pricing schemes on allocation of risk between the NHS and manufacturers were highlighted. The economic model developed formed the basis of the model used by ICER. ICER assessed tisagenlecleucel and axicabtagene ciloleucel in relapsed/refractory B-ALL and B-cell lymphoma, respectively. Base-case ICERs/QALY were $45,871 for tisagenlecleucel and $136,078 for axicabtagene ciloleucel vs. standard care, incorporating a pricing arrangement for tisagenlecleucel where payment was made only for responders at one month. Payment for axicabtagene ciloleucel was made at infusion. Based on an estimated 400 and 5,902 eligible patients, respectively, tisagenlecleucel did not exceed the $915 million budget impact (BI) threshold at any modelled price, while axicabtagene ciloleucel exceeded this threshold at all prices except the price to achieve an ICER of $50,000/QALY. A pricing discount of 11-28% would be required for axicabtagene ciloleucel to reach threshold prices. CONCLUSIONS: While tisagenlecleucel and axicabtagene ciloleucel are cost-effective at willingness-to-pay thresholds of $50,000 and $150,000 per QALY, respectively, the effect of pricing arrangements on net BI is highlighted. Management of BI, particularly in additional indications, will be a key HTA challenge.
Conference/Value in Health Info
2018-11, ISPOR Europe 2018, Barcelona, Spain
Value in Health, Vol. 21, S3 (October 2018)
Code
PCN301
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
Oncology